Hepatitis C, ChronicNCT00700401
POTENTE Study: A Study of Early Virological Response in Naive Patients With Chronic Hepatitis C, Genotype 2 or 3, Treated With PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Copegus (Ribavirin).
An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 12 sites in Brazil.
Trial summary
This single arm study will investigate the predictive value of a week 4 virological response on sustained virological response in patients with chronic hepatitis C, genotype 2 or 3, treated with PEGASYS + Copegus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- peginterferon alfa-2a [Pegasys] and ribavirin [Copegus]
- How many people
- 262 participants
- Where
- 12 sitesBrazil
- Study dates
- Nov 2008to Nov 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with serologically proven chronic hepatitis C and genotype 2 or 3, with or without cirrhosis and compensated liver disease (Child-Pugh A cirrhosis.)
Who may be able to join
- adult patients, >=18 years of age;
- positive serum HCV RNA.
Who cannot join
- co-infection with HIV or HBV (patients with a positive HBsAg);
- previous treatment with interferon, or peginterferon and/or ribavirin;
- severe hepatic dysfunction or decompensated cirrhosis of liver.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Brazil12 sites
Study site
Brasília, Federal District, 70335900
Study site
Campinas, São Paulo, 13060-803
Study site
Campinas, São Paulo, 13083-888
Study site
Porto Alegre, Rio Grande do Sul, 90020-090
Study site
Porto Alegre, Rio Grande do Sul, 90035-003
Study site
Ribeirão Preto, São Paulo, 14049-900
Study site
Rio de Janeiro, Rio de Janeiro, 20020-022
Study site
Santo André, São Paulo, 09060-650
Study site
São Luís, Maranhão, 65020560
Study site
São Paulo, São Paulo, 04040-003
Study site
Sorocaba, São Paulo, 18047-600
Study site
Vitória, Espírito Santo, 29043-260
About this study
Official title: A Prospective, Observational Study to Assess the Virological Response at Week 4 to the Therapy With PEGASYS® (Peginterferon Alfa 2a) Plus COPEGUS® (Ribavirin) in a Population of Treatment Naïve Patients With Chronic Hepatitis C, Genotype 2 or 3.
This single arm study will investigate the predictive value of a week 4 virological response on sustained virological response in patients with chronic hepatitis C, genotype 2 or 3, treated with PEGASYS + Copegus. Eligible patients will be treated with PEGASYS 180 micrograms/week sc + Copegus 800mg/day po; those who have a virological response at week 4 will continue to be treated for 24 weeks, followed by a 24 week treatment-free follow-up. Non-responders at week 4 will be entered into a separate protocol (MV21371) to receive PEGASYS + Copegus for 24 or 48 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.
- Conditions
- Hepatitis C, Chronic
- Being tested
- peginterferon alfa-2a [Pegasys], ribavirin [Copegus]
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peginterferon alfa-2a [Pegasys]Drug
180 micrograms/week sc for 24 weeks
ribavirin [Copegus]Drug
800mg po daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | Not described Receives: Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Sustained Virological Response at Week 48
Sustained Virological Response (SVR) is defined as participants with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks after the last dose of study drug. The detection limit of HCV RNA was 15 international units (IU) per milliliter (mL) by qualitative polymerase chain reaction (PCR).
Measured: At Week 48
Secondary outcomes (7)
Percentage of Participants With Rapid Virological Response at Week 4
Rapid Virological Response (RVR) is defined as participants with) undetectable HCV RNA at 4 weeks after initiation of the treatment period. The detection limit of HCV RNA was 15 IU/mL by qualitative PCR.
Measured: At Week 4
Percentage of Participants With Virological Response at Week 24
Virological response is defined as participants with undetectable HCV RNA after the last dose of study drug (Week 24).
Measured: At Week 24
Percentage of Participants With Virological Relapse
Virological relapse is defined as participants with virological response (undetectable HCV RNA) but did not achieve SVR.
Measured: At week 48
Percentage of Participants With Positive Predictive Value
Positive predictive value is defined as participants with RVR who did not achieve SVR.
Measured: At Week 48
Number of Participants With Any Adverse Events and Any Serious Adverse Events
An any adverse events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
Measured: Up to 48 weeks
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Hematology parameters included hemoglobin, hematocrit, leukocytes, neutrophils and platelets.
Measured: At Baseline (Day 0), Week 2, Week 4, Week 12, Week 24 and Week 48
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Biochemistry parameters included alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transpeptidase (Gamma-GT),fasting cholesterol, blood glucose, insulin, total bilirubin, creatinine, triglycerides, homeostatic model assessment score, prothrombin time (PT) and international normalized ratio (INR). The homeostatic model assessment (HOMA) score is a method used to quantify insulin resistance. HOMA score = (fasting glucose in mg/dL × fasting insulin in μIU/mL) / 405. A normal participant can have a HOMA score up to 3. A patient with a score of >3 is definitely insulin resistance. Low HOMA score indicate high insulin resistance, whereas high HOMA score indicate low insulin resistance.
Measured: Baseline, Week 4, Week 12, Week 24 and Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00700401
- Sponsor's protocol ID
- ML21543
- Status last verified
- May 2016
- First submitted
- 17 Jun 2008
- Last updated
- 21 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study to Assess the Virological Response at Week 4 to the Therapy With PEGASYS® (Peginterferon Alfa 2a) Plus COPEGUS® (Ribavirin) in a Population of Treatment Naïve Patients With Chronic Hepatitis C, Genotype 2 or 3.
- ClinicalTrials.gov ID
- NCT00700401
- Acronym / sponsor ID
- ML21543
- Conditions
- Hepatitis C, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 18 Jun 2008 (estimated)
- Results
- Posted 21 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single arm study will investigate the predictive value of a week 4 virological response on sustained virological response in patients with chronic hepatitis C, genotype 2 or 3, treated with PEGASYS + Copegus. Eligible patients will be treated with PEGASYS 180 micrograms/week sc + Copegus 800mg/day po; those who have a virological response at week 4 will continue to be treated for 24 weeks, followed by a 24 week treatment-free follow-up. Non-responders at week 4 will be entered into a separate protocol (MV21371) to receive PEGASYS + Copegus for 24 or 48 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peginterferon Alfa-2a + Ribavirin | – | Drug: peginterferon alfa-2a [Pegasys], Drug: ribavirin [Copegus] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with serologically proven chronic hepatitis C and genotype 2 or 3, with or without cirrhosis and compensated liver disease (Child-Pugh A cirrhosis.)
Key inclusion criteria (2 listed)
- adult patients, >=18 years of age;
- positive serum HCV RNA.
Key exclusion criteria (3 listed)
- co-infection with HIV or HBV (patients with a positive HBsAg);
- previous treatment with interferon, or peginterferon and/or ribavirin;
- severe hepatic dysfunction or decompensated cirrhosis of liver.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peginterferon alfa-2a [Pegasys]180 micrograms/week sc for 24 weeks | Drug | Peginterferon Alfa-2a + Ribavirin |
| ribavirin [Copegus]800mg po daily for 24 weeks | Drug | Peginterferon Alfa-2a + Ribavirin |
Primary outcome
Percentage of Participants With Sustained Virological Response at Week 48
Time frame: At Week 48
Sustained Virological Response (SVR) is defined as participants with undetectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at 24 weeks after the last dose of study drug. The detection limit of HCV RNA was 15 international units (IU) per milliliter (mL) by qualitative polymerase chain reaction (PCR).
7 secondary outcomes
Percentage of Participants With Rapid Virological Response at Week 4
Time frame: At Week 4
Percentage of Participants With Virological Response at Week 24
Time frame: At Week 24
Percentage of Participants With Virological Relapse
Time frame: At week 48
Percentage of Participants With Positive Predictive Value
Time frame: At Week 48
Number of Participants With Any Adverse Events and Any Serious Adverse Events
Time frame: Up to 48 weeks
Mean Percent Change From Baseline in Hematology Parameters at Weeks 2, 4, 12, 24, and 48
Time frame: At Baseline (Day 0), Week 2, Week 4, Week 12, Week 24 and Week 48
Mean Percent Change From Baseline in Biochemistry Parameters at Weeks 4, 12, 24 and 48
Time frame: Baseline, Week 4, Week 12, Week 24 and Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hepatitis C, Chronic
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 12 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Sustained Virological Response at Week 48 (time frame: At Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2016.